MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE 3.0PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	PS210-030P
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that when the doctor used the handpiece at the beginning of the operation, he found sparks from the handpiece tip.The doctor tried to adjust the energy to avoid sparks, but after several tests, there were still sparks on the tip of the handpiece tip.Finally, the doctor replaced a new handpiece to complete the operation.There was no impact to patient outcome.

• Brand Name: PLASMABLADE 3.0PLUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11946718
• Report Number: 1226420-2021-00094
• Device Sequence Number: 19878647
• Product Code: GEI
• UDI-Device Identifier: 00643169617131
• UDI-Public: 00643169617131
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K102709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: PS210-030P
• Device Catalogue Number: PS210-030P
• Device Lot Number: 0219880759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1